Method for collecting cellular material by circulating a fluid within a body cavity

ABSTRACT

A washing method for irrigating a body cavity using an apparatus having an inlet tube which is open at both ends, and is adapted to have its forward end extend into a body cavity and its rear end connected to a source of washing fluid. Additionally, an outlet tube, which is open at both ends forms part of the apparatus. The inlet tube has its forward end adapted to extend into the body cavity with its rear end connected to a source of suction. A sealing member is positioned on the outlet and inlet tubes intermediate their ends and is adapted to seal the entrance to the body cavity. In operation, the source of suction provides a negative pressure to the body cavity and washing solution will pass through the inlet tube into the body cavity, accumulate cells and matter therefrom and pass through the outlet tube to a collection point.

o United States Patent 1151 3,636,980 Gravlee 51 Jan. 25, 1972 [54] METHOD FOR COLLECTING 883,583 3/1908 Stallsmith ..128/240 CELLULAR MATERIAL BY 1,211,928 1/1917 Fisher ....128/240 IR LA F 1,603,758 10/1926 Fisher ....l28/250 $i$ A LUID WITHIN A 1,915,803 6/1933 Simpkins ....128/240 2,148,541 2/1939 Dierker.... ....l28/24l [72 Inventor: Leland C Gravlee, 350 Brookwood 2,544,931 Marco H: I 28/2 Road7 Mountain Brook Ala 35223 3,144,868 8/]964 JaSCZIBVIClI ..l28/276 X 2] Filed! M 1970 Primary Examiner-Richard A. Gaudet Assistant Examiner-Kyle L. Howell 21 A LN 18,18 1 pp 0 4 Attorney-Kane, Dals1mer, Kane, Sull1van and Kurucz Related US. Application Data [57] ABSTRACT 60 Division of Ser. No. 688,723, Dec. 7, 1967, Pat. No.

3,527,203, which is a continuatiomin-part of Ser. No. A Washmg method for lmgatmg a y cavity g an p- 421 013 Dec. 24 1964, abandone paratus having an inlet tube which is open at both ends, and is adapted to have its forward end extend into a body cavity and 521 user ..128/2B,128/241, 128/278 its rear end connected to some of Washing fiuid- Addi- 51 int. c1. ..A6lb 10/00 Iionally, an Outlet tube, which is p at both ends forms P [58] Field 01 Search 128/2, 2 B, 240, 241, 227, of the apparatus The inlet tube has iis forward end adapted to 128/228, 276, 278, 350, 2 F, 2 w extend into the body cavity with its rear end connected to source of suction. A sealing member is positioned on the out 5 References Cited let and inlet tubes intermediate their ends and is adapted to seal the entrance to the body cavity.. In operation, the source UNITED STATES PATENTS of suction provides a negative pressure to the body cavity and washing solution will pass through the inlet tube into the body igi; gigg cavity, accumulate cells and matter therefrom and pass 493,208 3/1893 Cruickshank n 128/278 UX through the outlet tube to a collection point. 750,276 [/1904 Gruss 128/240 3 Claims, 6 Drawing Fi PATENIED JAN25 1972 SHEET 2 [IF 2 FIG. 3

FIG. 4

INVENTOR ZfLA/VID C. GPAVL/TE J% ATTORNE ll METHOD FOR COLLECTING CELLULAR MATERIAL BY CIRCULATING A FLUID WITHIN A BODY CAVITY CROSS-REFERENCE TO RELATED APPLICATIONS This application is a division of my previous application, Ser. No. 688,723 which was filed on Dec. 7, 1967, now Pat. No. 3,527,203, and which is a continuation-in-part of my previous application, Ser. No. 421,013 filed Dec. 24, 1964, now abandoned.

BACKGROUND OF THE INVENTION In the field of diagnosing various types of intrauterine cancer such as endometrial carcinoma in its early states, the known methods for obtaining cells for diagnosis are not entirely satisfactory. There is a considerable need for an improved diagnostic method which will greatly improve the results.

As is well known in the art, with the aging population, the occurrence of endometrial carcinoma is rapidly approaching a one-to-one ratio with the occurrence of carcinoma of the cervix. Endometrial carcinoma is in marked contrast to carcinoma of the cervix uteri with regard to early diagnosis. The recognition of cervical carcinoma in an asymptomatic patient while the lesion is still intraepithelial is almost exclusively the result of advances in exfoliative cytology. Endometrial carcinoma, on the other hand, is rarely diagnosed in the asymptomatic patient and while it is frequently an indolent cancer of slow development, this biological feature is not reflected in survival statistics. Accordingly, if patient salvage is to be improved in cases of endometrial carcinoma, early diagnosis must be made more frequently than is possible with conventional or routine vaginal or cervical smears.

Routine vaginal and cervical smears are unsatisfactory for use in detecting endometrial carcinoma due to the fact that the endometrium does not exfoliate as readily as the cervix uteri or vagina. Accordingly, the number of cells reaching the vaginal pool is relatively small and the cells themselves frequently degenerate whereby the whole sample is heavily diluted by material from the cervix and vagina.

Various devices have been proposed to increase the efficiency of the test for endometrial carcinoma, such as the introduction of the sterile saline solution under pressure. This procedure has been found to be unsatisfactory due principally to the fact that diseased cells are often forced into other cavities, such as the Fallopian tubes thereby spreading the disease to other parts of the body. Additionally, rotary brush units have been employed, however, such units are unsatisfactory since they are difiicult to sterilize and a possibility also exists that bristles will break off during the sampling process and thereby cause irritation and inflammation to the interior parts ofthe patient.

From the above, it is apparent that there is a need in the art for the provision of an intrauterine sampling method which will produce a sufficient and desirable amount of cell tissue for effective diagnosis. A method would be desirable which would avoid the problem of possible irritation of the inner parts of the patient and in particular the problems coexistent with many painful procedures of examination. In this manner, the necessity of an anesthetic is eliminated thereby allowing the doctor to simply obtain a sample in his office quickly and efficiently. Naturally as discussed above, it would also be advantageous to provide a sampling or washing method which would alleviate the danger of cells being washed to other parts of the body such as out of the Fallopian tubes.

With the known types of sampling methods, practice thereof is often very painful and requires an anesthetic to be used as well as other considerations for the comfort of the patient.

Another existent problem with methods wherein devices are inserted into the uterus is the danger of the device being inserted too far so that it will pierce the uterus wall causing serious internal damaged to the patient. Therefore, it would be advantageous to have an adjustable device whereby the distance it extends into the uterus can be regulated for the particular different size or shape of a uterus.

It should be kept in mind that although the washer has use in intrauterine diagnosis, particularly for the use of diagnosing endometrial carcinoma as described herein for exemplary purposes, it is also possible to adapt the device for many other uses such as in the lungs. In a similar manner, a sampling of tissue may he removed from the lungs for testing purposes. Furthermore, the washer may be used. for radiation therapy in which radio opaque dye may be irrigated through the uterus. Also, this device as well may be used as a means of introducing therapeutic medicament in that the application of the fluid is localized.

SUMMARY OF THE INVENTION A method of irrigating a body cavity using an apparatus consisting principally of an inlet tube, an outlet tube and a sealing member. The inlet tube is open at both ends and has its forward end adapted to extend into the body cavity when in position and its rear end is adapted for connection to a source of washing fluid. The outlet tube is also open at both ends and when in position has its forward end extending into the body cavity and its rear end is adapted for connection to a source of suction. The sealing member is positioned intermediate the ends and on the tubes and is adapted to seal the entrance to the body cavity. When suction is applied to the outlet tube a negative pressure is created in the body cavity and washing solution passes through the inlet tube into the body cavity, accumulates cells and matter therefrom and then exits through the outlet tube for collection.

It is a primary objective of this invention to alleviate the above-mentioned problems by providing a method of irrigating a body cavity which provides a negative pressure within the body cavity while collecting a highly desirable amount of cell tissue for analysis thereby minimizing the danger of malignant material entering the other body passages.

Another object is to provide a method which may be easily and painlessly practiced in the doctors office without the necessity of administering an analgesic or anesthetic to the patient while still obtaining an improved sample of tissue for further diagnostic process.

Other objects and advantages will become apparent from the following detailed description which is to be taken in conjunction with the accompanying drawing illustrating a preferred embodiment of this invention.

BRIEF DESCRIPTION OF THE DRAWING With the foregoing in mind, reference is made to the accompanying drawing in which:

FIG. 1 is a side view of a washing apparatus embodying this invention;

FIG. 2 is a schematic view thereof showing the device in position within a uterus and being connected to a suction source and a source of washing solution;

FIG. 3 is a fragmentary sectional side view of the forward portion of a washing apparatus embodying this invention;

FIG. 4 is a fragmentary side elevation view of the forward portion of the outlet tube part of a washing apparatus embodying this invention;

FIG. 5 is a sectional end view of the: forward portion of a washing apparatus embodying this invention taken along the plane of line 5 5 of FIG. 3; and

FIG. 6 is a sectional end view thereof taken along the plane of line 6-6 ofFIG. 3.

DESCRIPTION OF THE PREFERRED EMBODIMENT As stated above, the washing apparatus of this invention is useful for many applications, however, for descriptive purposes, the device will be applied as in intrauterine washing device in the following discussion.

As shown in FIG. I, the intrauterine washing apparatus 20 is comprised basically of three main parts. There is an inlet tube 21, an outlet tube 22, and a sealing member 23.

Inlet tube 21 has an adapter 24 at its rear end which may be connected to a source of washing solution. At the other end of inlet tube 21 is a series of aligned apertures 25 along the end portion surface thereof and an opening 26 at the forward end.

The outlet tube 22 has an adapter 27 at its rear end for connection to a source of suction. At its forward end it also has a series of apertures 28 adjacent the end and an opening 29 at its end.

Inlet tube 21, outlet tube 22, and apertures 24 and 27 are generally constructed of a low-cost plastic material however, other materials well known in the art having similar properties will work satisfactorily. The forward portions of inlet tube 21 and outlet tube 22 are fastened in a permanent connection by any common well-known nontoxic adhesive means. Adapters 24 and 27 are similarly fastened to the rear end of tubes 21 and 22. It should be noted that, alternatively, inlet tube 21 and outlet tube 22 may consist of a body of one-piece plastic construction with two separate passageways therein to form tubes 21 and 22.

Turning to FIGS. 3-6, the forward portions of inlet tubes 21 and outlet tube 22 can be observed in greater detail. To obtain the desirable negative pressure within the uterus when the washer is inserted therein, it will be observed that outlet tube 22 is of a considerably larger diameter than inlet tube 21. Furthermore, there are a larger number of apertures 28 in outlet tube 22 than there are apertures in inlet tube 21. In addition, apertures 28 are also of a considerably larger diameter than apertures 25. This aids in providing a negative pressure within the uterus and helps in minimizing the danger of too great an amount of fluid being within the uterus during the washing operation.

It should also be noted that there are three apertures 30 which extend through the adjoining surfaces of inlet tube 21 and outlet tube 22 which thereby communicate the passages through tubes 21 and 22. Holes 30 are valuable in initiating the washing action when the device has been inserted into the uterus by serving to aid in providing a priming action.

Turning to the adjustable stop 23, it is generally constructed of a rubber material although other well-known materials would be adequate, and is acorn in shape so as to facilitate its insertion into the opening to the uterus and the forming of a proper seal therein. Sealing member 23 has an opening therein corresponding to the combined configuration of the cross section of inlet tube 21 and 22 as seen in FIG. 6. The size of the opening that a tight-fitting engagement will be initiated between sealing member 23 and tubes 21 and 22 when it is positioned thereon. However, the engagement is such that, with an application of sufficient force, sealing member 23 may be slidably moved along the adjoining surfaces of tubes 21 and 22 so that washer 20 may be adjusted in size to correspond to the particular size and shape of the uterus being examined.

In operation, as shown in FIG. 2, the washer is inserted into the opening in the uterus until sealing member 23 enters into sealing engagement with the lower portion thereof. By prior examination the proper length of the forward portion of tubes 21 and 22 can be determined and the device properly adjusted so that it will not extend too far into the uterus and pierce the rear or upper walls thereof causing internal damage to the patient.

Generally, the particular configuration and shape of the uterus will cause it to have its lower portion positioned'adjacent to the openings in inlet and outlet tubes 21 and 22 when the washer 20 is properly positioned. As shown, adapter 24 is positioned into a beaker of saline solution 32. Beaker 32 is merely exemplary as many types of devices for holding the saline solution. Likewise, adapter 27 is connected to the forward end of a syringe 33 which will provide a source of vacuum when plunger 34 is drawn from barrel 35. Naturally, other types of vacuum-producing devices well known in the art will work adequately in place of syringe 33.

As plunger 34 is removed from syringe barrel 35, negative pressure will be created within uterus 36 and saline solution will flow through inlet 21 and will exit through apertures 25 in the forward portion thereof. It is generally believed that the flow of the solution will be at substantially right angles to the longitudinal axis of inlet tube 21 as it exits therefrom so that it will come in contact with the adjacent wall of uterus 36 and gather tissue therefrom. A small amount of fluid will also exit from end opening 26 of inlet tube 21.

It should also be noted that, as discussed above, a priming action also occurs because of fluid flowing through apertures 30 into the adjacent larger diameter outlet tube. This initiates the proper flow pattern and turbulence and the fluid within the uterus will generally circulate in the lower portion thereof and the majority of it will enter larger apertures 28 in the outlet tube carrying with it a good sampling of tissue for diagnosis. A small portion of the fluid within the uterus will also exit through opening 29 in the end of outlet tube 22. The fluid and tissue combination will exit through outlet tube 22 in syringe 33 for collection and later testing.

The fact that outlet tube 22 is of a much larger diameter than inlet tube 21 and that holes 28 are of a larger number and a larger diameter than holes 25, facilitates the provision of negative pressure within the uterus so that the fluid may exit more freely than it enters the uterus. In this manner, the uterus does not fill up with fluid which could cause some of the fluid and possibly undesirable tissue to enter Fallopian tubes 31. Furthennore, in some instances, the negative pressure within the uterus may be great enough so as to cause the Fallopian tubes to be squeezed together and thereby closing off the entrance thereto which would of course render it substantially impossible for any malignant tissue to enter the Fallopian tubes 31.

Apertures 28 and 25 have roughened edges thereon which aids in enabling tissue to collect at the entrance to these holes thereby providing a better sample when the washer is inserted or removed. Furthermore, as the washer is removed these roughened edges will perform a scraping operation to remove additional tissue from the adjacent sidewalls of the uterus and entrance thereto which also adds in obtaining the most desirable sample for testing. The cells collected by all of the abovediscussed means when using washer 20 provide a very effective sampling for diagnostic purposes. Therefore, the results obtained by using the washer 20 have been much improved over any other known methods.

It should also be kept in mind that the use of washing apparatus 20 causes a minimal amount of discomfort to the patient. There is relatively no accompanying pain during the sampling operation. Therefore, there is no need for any anesthetic to be used and the device may be used right in the individual doctor orrrca THEREBY FACILITATING THE RAPID AND EARLY DETECTION OF ANY MALIGNANCY IN THE UTERUS.

When the doctor is to use the device in his office, in order to obtain a proper sample, he begins by the normal operations of inserting an unlubricated speculum into the vagina and doing Pap smear tests of the cervix in a routine manner. He then removes the speculum and does a bimanual examination while noting the sides and position of the uterus. He then reintroduces the speculum and cleans the cervix with a cleansing solution. He sounds the uterus to determine the adjustment necessary for the sealing member further probing the entire uterine cavity with the sound sufliciently to aid in the loosening of cells for the later washing operation. He then adjusts sealing member 23 of the washer 20 to provide the proper length of the tubes to extend into the uterus. The washer is then extended into the patient until sealing member 23 forms a seal in the mouth of the cervix. inlet tube 21 is then inserted into the receptacle holding the sterile saline solution and a syringe or similar device is attached to outlet tube 22 for providing the proper vacuum. The plunger is then withdrawn to draw a desired amount of solution into the syringe. This specimen is then expelled from the syringe into a standard centrifuge tube or similar device for processing in the laboratory. The washer 20 may then be disposed of or it may be resterilized for further use.

Thus the aforementioned objects and advantages are most effectively attained. Although a preferred embodiment of this invention has been disclosed in detail herein, it should be understood that this invention is in no sense limited thereby, and its scope is to be determined by that of the appended claims.

What is claimed is:

l. A method for collecting cellular material from the inner walls of the uterus in a manner which will facilitate obtaining a sample from a substantial portion of the inner walls of the uterus without subjecting the patient to undue pain or discomfort comprising:

sealing the uterus;

subjecting the interior of the uterus to a negative pressure and simultaneously therewith drawing into the uterus a washing fluid in the form of a spray whereby the fluid will contact the inner walls of the uterus and will accumulate cellular and other material therefrom; and

extracting the washing fluid together with the cellular material from the uterus while retaining the uterus in a negative pressure condition while continuously drawing washing fluid into the uterus so that only a minimum amount of washing fluid is retained in said uterus at any given time to thereby alleviate the danger of passage of the fluid containing collected matter to other portions of the body prior to extraction thereof from the uterus for collection and ultimate testing purposes.

2. The invention in accordance with claim 1 wherein the fluid is passed through a pair of adjacent tubes having openings in both ends thereof with the forward end of each tube adapted to be positioned within the uterus and the rear end of each tube adapted to be connected respectively to a source of washing fluid and a source of suction so that when said tubes are properly positioned and connected washing fluid will be drawn through one of said tubes into said uterus and thereafter from said uterus through the other of said tubes into a collection container associated with said source of suction carrying therewith collected cellular and other matter from the uterus.

3. The invention in accordance with claim 2 wherein sealing of the uterus is accomplished by an adjustable sealing member slidably mounted on said tubes in sealing engagement therewith and being adapted to be positioned in sealing engagement with the entrance to the uterus.

4. The invention in accordance with claim 2 wherein the fluid passing through one of said tubes into the uterus is drawn through a row of aligned holes in the exterior surface of the one tube so as to contact the inner walls of the uterus in the form of a spray, the other of said tubes containing a plurality of openings through which the washing fluid and collected matter will pass when being drawn from the uterus into said other tube for collection, the area of the openings in said other tube being greater than the area of the openings in said one tube to facilitate removal of the washing fluid from the uterus without undue accumulation of fluid within the uterus.

5. The invention in accordance with claim 4 wherein the row of aligned holes in said one tube are in the wall distal from said other tube and in direct communication with the walls of the uterus so that when said washing fljuid passes through said row of aligned openings it will directly contact the walls of the uterus, and at least one communicating passageway between said adjacent tubes and opening on the adjacent walls of the forward portions thereof to facilitate initiation of the proper flow of washing fluid upon commencement of the collection process.

6, The invention in accordance with claim 3 wherein the outer edges of the openings in both of said tubes facilitate collection of additional cellular material to be later collected from said tubes and placed within the container containing the collected washing fluid and previously accumulated cellular and other matter.

7. The invention in accordance with claim 1 wherein prior to scaling of the uterus, the uterus is sounded to assist in properly ascertaining the location and depth of the uterus.

8. The invention in accordance with claim 7 wherein the uterus is probed with the sound sufficiently by contacting the uterus inner walls with the sound to aid in the loosening of cells for the later washin g operatio l.

@2 33 UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 3,636,940 Dated January 25, 1972 i s f Leland C. Gravlee It is certified that error appears in the above-identified patent and that said Letters Patent are hereby corrected 'as shovm below:

Column 1, line 14, "states" should be --stages- Column 3, line 7, "apertures" should be --adapters-F Column 3, line 44, afte r"opening" insert --to' receive tubes 21 and 22 is of such a dimensione Signed and sealed this 15th da of- August 1972.

(SEAL) Attest:

EDWARD M.FLETCHER,JR. ROBERT GOTTSCHALK Attesting; Officer Commissioner of Patents 

1. A method for collecting cellular material from the inner walls of the uterus in a manner which will facilitate obtaining a sample from a substantial portion of the inner walls of the uterus without subjecting the patient to undue pain or discomfort comprising: sealing the uterus; subjecting the interior of the uterus to a negative pressure and simultaneously therewith drawing into the uterus a washing fluid in the form of a spray whereby the fluid will contact the inner walls of the uterus and will accumulate cellular and other material therefrom; and extracting the washing fluid together with the cellular material from the uterus while retaining the uterus in a negative pressure condition while continuously drawing washing fluid into the uterus so that only a minimum amount of washing fluid is retained in said uterus at any given time to thereby alleviate the danger of passage of the fluid containing collected matter to other portions of the body prior to extraction thereof from the uterus for collection and ultimate testing purposes.
 2. The invention in accordance with claim 1 wherein the fluid is passed through a pair of adjacent tubes having openings in both ends thereof with the forward end of each tube adapted to be positioned within the uterus and the rear end of each tube adapted to be connected respectively to a source of washing fluid and a source of suction so that when said tubes are properly positioned and connected washinG fluid will be drawn through one of said tubes into said uterus and thereafter from said uterus through the other of said tubes into a collection container associated with said source of suction carrying therewith collected cellular and other matter from the uterus.
 3. The invention in accordance with claim 2 wherein sealing of the uterus is accomplished by an adjustable sealing member slidably mounted on said tubes in sealing engagement therewith and being adapted to be positioned in sealing engagement with the entrance to the uterus.
 4. The invention in accordance with claim 2 wherein the fluid passing through one of said tubes into the uterus is drawn through a row of aligned holes in the exterior surface of the one tube so as to contact the inner walls of the uterus in the form of a spray, the other of said tubes containing a plurality of openings through which the washing fluid and collected matter will pass when being drawn from the uterus into said other tube for collection, the area of the openings in said other tube being greater than the area of the openings in said one tube to facilitate removal of the washing fluid from the uterus without undue accumulation of fluid within the uterus.
 5. The invention in accordance with claim 4 wherein the row of aligned holes in said one tube are in the wall distal from said other tube and in direct communication with the walls of the uterus so that when said washing fluid passes through said row of aligned openings it will directly contact the walls of the uterus, and at least one communicating passageway between said adjacent tubes and opening on the adjacent walls of the forward portions thereof to facilitate initiation of the proper flow of washing fluid upon commencement of the collection process. 6, The invention in accordance with claim 3 wherein the outer edges of the openings in both of said tubes facilitate collection of additional cellular material to be later collected from said tubes and placed within the container containing the collected washing fluid and previously accumulated cellular and other matter.
 7. The invention in accordance with claim 1 wherein prior to sealing of the uterus, the uterus is sounded to assist in properly ascertaining the location and depth of the uterus.
 8. The invention in accordance with claim 7 wherein the uterus is probed with the sound sufficiently by contacting the uterus inner walls with the sound to aid in the loosening of cells for the later washing operation. 